Equalizer
FDA 510(k) K780617 · Ballert Orthopedic Corp.
510(k) numberK780617
Submission
- Device name
- Equalizer
- Applicant
- Ballert Orthopedic Corp.
Mchenry, IL, US - Received
- April 13, 1978
- Decision date
- April 18, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IPG – Shoe, Cast
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3025
- Specialty
- Physical Medicine
Other 510(k)s with product code IPG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K024279 | Ness Children SystemIPG · Traditional | Ness-Neuromuscular Electrical Stimulation Systems | 02/05/2003SE |
| K790652 | ToguardIPG · Traditional | Togard, Inc. | 04/04/1979SE |
| K781363 | Cast ShoeIPG · Traditional | Cutler Biomedical | 08/14/1978SE |
| K760575 | Rocker-Sole Cast SandalIPG · Traditional | Richard'S Medical Equip., Inc. | 10/06/1976SE |
| K760578 | Balanced Cast SoleIPG · Traditional | Parke-Davis Co. | 09/27/1976SE |
More from Parke-Davis Co.
| 510(k) | Device | Decision |
|---|---|---|
| K771988 | VertetracHST · Traditional | 02/01/1979SE |
Questions and answers
When was Equalizer cleared by the FDA?
Equalizer (K780617) received a 510(k) decision of Substantially Equivalent on April 18, 1978, 5 days after the submission was received.
What is the product code of K780617?
The FDA product code is IPG – Shoe, Cast, a Class I (low risk) device regulated under 21 CFR 890.3025.